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FDA 510(k)

Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri

K-Number: K192775 · 2019-10-30

ApplicantStereotaxis, Inc.
Decision Date2019-10-30
Product CodePJB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri is the device name listed in this FDA 510(k) record. The listed applicant is Stereotaxis, Inc.. It received FDA 510(k) clearance on 2019-10-30 under 510(k) number K192775. The device is classified under product code PJB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri?

Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri is a medical device that received FDA 510(k) clearance on 2019-10-30. The listed applicant is Stereotaxis, Inc.. The 510(k) number is K192775.

When did Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri receive FDA 510(k) clearance?

Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri received FDA 510(k) clearance on 2019-10-30, under 510(k) number K192775.

Who is the listed applicant for Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri?

The FDA 510(k) record lists Stereotaxis, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri?

The FDA product code for Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri is PJB.

Other records listing Stereotaxis, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P240014Cardiac ablation percutaneous catheterK253473SynchronyK251792Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)K250590MAGiC Sweep™ EP Mapping CatheterK193147Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive SystemK183027Steerable catheter control system

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Related Devices (Code: PJB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K193147Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive SystemStereotaxis, Inc.K183027Steerable catheter control systemStereotaxis, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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